Frontier Science in Amherst, NY is the data management center for the AIDS Clinical Trials Group (ACTG) and International Maternal Pediatric & Adolescent AIDS Clinical Trials (IMPAACT) Network, projects funded by the National Institutes of Health (NIH).
The CDISC Coordinator, leading a team of Specialists devoted to implementing Clinical Data Acquisition Standards Harmonization (CDASH) and Study Data Tabulation Model (SDTM) foundational standards to clinical trials, is responsible for managing CDISC-related activities at Frontier Science, coordinating the workflow for the creation of compliant collection instruments and datasets, and staying informed of changes and developments related to CDISC. Additional duties and responsibilities include but are not limited to:
- Liaising with relevant technical staff and Statisticians to develop a workflow for creation of CDASH compliant data collection instruments and SDTM data sets for CDISC studies
- Maintaining validation and QA/QC procedures to insure data integrity of CDISC data flow
- Working with technical writers to develop and maintain CDISC related SOPs and work instructions
- Supervising the work of the SDTM Specialist and programmers
- Acting as the Project Manager for formal CDISC data submissions
- Overseeing and monitoring CDISC controlled terminology and Implementation Guide updates
- Providing expertise and guidance to staff working with CDISC foundational standards
- Maintaining communication with the Sponsor and statisticians on CDISC submission studies
- Keeping up with all publications and updates from cdisc.org and the FDA regarding CDISC
- Relaying relevant information and provide status updates on current projects to the Office Director
- Leading CDISC related working groups as needed
- Setup and conduct of internal training as needed
- Presenting CDISC workflows and associated processes to external clients, statisticians, and auditors.
Candidates will be working in a dynamic, fast-paced environment and need to be comfortable learning and working with a variety of software programs. Experience with the Medidata Rave EDC is preferred, but not required.
A Bachelor's degree in a Science, Math, Biostatistics, or a closely related field as well as excellent communication skills, both written and verbal, are required. This person must also be driven, a team player, able to multi-task, and have excellent attention to detail. At least three years of experience in data management, specifically project management, on clinical trials is highly preferred as well as SDTM experience, preferable in clinical research or pharma programming. Proficiency in SQL and MS Excel, as well as knowledge of relational database structures and complex data systems is a plus.
This position is located in our Amherst, NY office and cannot be done remotely.
Submit resumes to firstname.lastname@example.org and include CDISC_Coord in the subject line.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, or veteran status.